CN102481112A

CN102481112A - Wound dressing with impedance sensor

Info

Publication number: CN102481112A
Application number: CN201080030980XA
Authority: CN
Inventors: 帕特里夏·康诺利
Original assignee: University of Strathclyde
Current assignee: University of Strathclyde
Priority date: 2009-07-10
Filing date: 2010-07-09
Publication date: 2012-05-30
Anticipated expiration: 2030-07-09
Also published as: ES2584312T3; CA2767292A1; GB0912009D0; US20120190956A1; CA2767292C; EP2451349B1; EP2451349A1; CN102481112B; JP2012532642A; US10716490B2; WO2011004165A1

Abstract

A wound sensor comprising at least one electrode (10a, 10b) and a non-adherent porous layer (25) proximate at least part of the electrode.

Description

The wound dressing that has impedance transducer

The present invention relates to pick off.Particularly, the present invention relates to be used for confirming the pick off of wound status.Background of invention

Can monitor wound status and for example check that whether healing speed and/or definite wound dressing or the treatment of wound obtain optimal placement is useful.The pick off that has been proposed to be used in the monitoring wound is monitored biomarker, enzyme and the humidity that multiple parameter comprises pH, temperature, tissue closure, infection, healing.But in the practice owing to be difficult to create and can stay on the wound or in wound dressing and do not cause pick off to the interferential economy of processing by the avirulence sterile material of agglutination, in clinical for the patient who lives what proof not also all almost.

Measurement wound to dressing at the interface or the humidity in wound dressing be important.This is because of in wound, keeping appropriate level of humidity for preventing that wound from becoming wet or overdrying can be important.Optimal healing only occurs under moistening (moist) condition in most wounds.The wound of wet (wet) is macerated and is organized further and destroy.Thereby if its wound that to be big zone do can not fine healing or their healings but usually adhering to wound dressing causes pain and damage when removing dressing.

Wound is monitored normally difficult, because it possibly need to remove wound dressing, removing wound dressing can influence healing.The wound monitoring sensor is available, but these possibly be problematic, because this pick off possibly use the material that disturbs or stimulate wound.Advised adopting the sensor array of the pattern form on the insulant.Yet, in the practice, these wound closure and cause that skin macerates.Equally, the pick off of some types adheres to wound, when they are removed, can cause the wound damage.Some pick offs also disturb the healing of wound through disturbing humidity control, and some only have the limited life-span in wound environment and by exudate, blood or the influence of other wound materials.Equally; The verified humidity sensor that is used for clinical field that provides such of being difficult to up to now; It can be quantified as humidity and measure such as dried (dry)-moistening (moist)-wet (wet) being present in humidity in the wound dressing, thereby allows the clinician under the situation of not removing dressing, change dressings more to be maked decision.

EP 0,403, and 608 A have described the pick off that is used for wound dressing, and said pick off comprises the responsive to temperature off-color material.Because the change of blood flow and wound infection can change temperature, so if can find stable and nontoxic material and it is shaped so that keeps that this can have some practicality with contact skin.

DE 4014572 A1 have described the humidity system that is used for responding to the binder blood flow.This D.C. resistance that will be used to survey humidity is measured with the optical pickocff that is used to survey the blood characteristics color and is combined.Yet, thereby DC measurement can cause the electrochemistry of electrode and the formation that dissolving causes near the new chemicals of wound, perhaps discharges the component of electrode, thereby introduces possible toxic action and change the wound healing environment from its natural conditions.Equally, the variation of Wound exudate ion concentration and ion migration makes D.C. resistance very variable.It incites somebody to action not activation threshold value humidity very high D.C. resistance for example in still moistening thick transudate, can to occur.

JP 2002-224093 has described and has been used for printing (printed) pick off that diaper humidity is surveyed.Described pick off is through the change detection humidity of this pick off selfcapacity.It is constructed like this so that thereby the electrostatic field of this sensor electrode is occurring changing the localized variation of introducing impedance under the situation of moisture, and the localized variation of impedance is the basic variation to this sensor capacitance.Between induction electrode, always exist complete insulating barrier that thereby fixed dried electric capacity and known electrostatic field are provided.Though but the impedance variation of introducing is relatively little and be not quantitatively threshold value to be set for each pick off in the array to allow to survey the not diffusion of the flat humidity of gauge water.This equipment is surveyed " wetting " or " not wet " pattern of crossing over sensor array.

JP 295726 has described and in fixed layer, has caught urine and indicate the humidity sensor that moisture occurs.It is inappropriate for wound contacting because it is designed to catch liquid between the electrode by waterproof ES protection in being in water accepting layer.It is said this be used for diaper because it will always catch liquid and therefore this equipment will always show when to urinate and even it has taken place be read in this equipment a little earlier.Do not produce humidity in the diaper quantitatively or monitoring in time.

JP 2004 85277A have described such humidity sensor, and said humidity sensor only is applicable in the skin use of dressing or binder and need be covered by the wet stock that do not pass through that wherein has the hole.Saidly do not pass through the effective capacitance device that wet stock is designed to protect the sensor electrical interpolar, said effective capacitance device will change electric capacity when moisture gets into the pervious bed in said hole or the equipment.This equipment can not be used for wound dressing because the thoroughly not wet barrier of protection pick off will be caught wound fluid and caused macerating of skin.Likewise this equipment is surveyed wet or is done, but does not have the not commensurability ability of surveying humidity.

WO2004/049937 and WO29092616A have described the rectangular electrode array that can be used for electricity irritation wound tissue or measure wound tissue's impedance.Measurement electrode is separated each other such as the non-conducting water gel that parches by the barrier layer.In use, the conduction portion of stimulating electrode directly contacts with wound tissue via the hydrogel sheet (patch) on the conducting electrode that exposes.Therefore, they are designed to not measure above the wound with organizing electricity to link to each other or the humidity of localized site between the electrode.In the practice, make said electrode do in callus and cling the cellular layer of healing.Remove this equipment and wound dressing and will remove the skin of healing.Hydrogel is applied to electrode alleviates this problem hardly during agglutination because this also will parch.

FR 2682487 has described such monolithic electrode, thereby said monolithic electrode is actually and can be applied to living tissue and be used to send the conduction mesh (mesh) that voltage or electric current stimulate this tissue.It directly is placed on heart tissue for being used to make the high relatively voltage and current design of cardiac defibrillation and be predefined for specially.This conduction mesh will all contact at random with tissue, blood and moisture and contact with the tissue of living, and will have according near said tissue or the mobile albumen of said tissue and the self-impedance at random of cellular change.Therefore it is inappropriate for the humidity of only monitoring in the wound dressing and can not be very suitable for the electricity treatment is delivered to the wound that is healing.If on regional area, need local impedance to measure, the structure of this pick off is inappropriate for as " paired electrode " it.

US 4,611, and 604 have described in cardiac pacemaker, to be used as and return or by the electrode of moving electrode.This electrode is to be coated with the metal of porous material and to have high double layer capacity.The porous layer cover layer (coating) of this electrode is conductive and is nitride, carbide or equivalent that some are such.Therefore, porous layer be electrode part and with its electricity link to each other.

US 4,603, and 704 have described this high double layer capacity system further developing at the single electrode that is used for the voltage stimulation.US 4,573, and 480 have described and are used for the another kind of arrangement of electrodes used at cardiac pacemaker.This has the porosity that gives its flexibility but cannot let body fluid get into.This is the useful cover layer that still is not suitable as humidity sensor in the insulation environment.Other combine electrode shape with insulating cover, said insulating cover comprises such as at US 5,466, the flexible outer layer in 252.The equipment of this type also is useful for implantable, the insulating electrode that are used for cardiac stimulation, but of no use for the monitoring of the local humidity in wound dressing.

WO099644A2 has described AC impedance and frequency is chosen in the quantification wound dressing or the purposes among the humidity level at wound interface place.Can monitor the humidity level in time quantitatively.This allow to monitor in time exudate flows and monitoring in the dressing performance and the aquation of diverse location.

Although known multiple tissus sensor and electrode; No matter contacting is to take every caution against error in the surveillance equipment healthy, damage or ill skin, thus (a) said equipment do not cause more local tissue damage and (b) said equipment correctly monitor in the medical treatment or the parameter of being concerned about in the nursing.Summary of the invention

According to a first aspect of the invention, the wound pick off is provided, said wound pick off comprises at least one electrode and does not adhere to porous layer near the said electrode of part at least.

The present invention provides such humidity sensor, and said humidity sensor can not disturb agglutination to the grading of the humidity level in wound surface place or the said wound dressing in wound dressing.Said pick off can be placed in the said dressing between healing stage for a long time.

Use among this paper do not adhere to be defined as is adapted to resist the adhesion to wound or callus.

Said porous layer can be medical surface, material or cover layer, such as biocompatible and/or non-irritating is surperficial, material or cover layer.

Said pick off can comprise two or more electrodes.Said at least one electrode can be placed in the substrate.Said substrate can be not adhere to substrate.Said substrate can be an electrical insulating substrate.Said substrate can be adapted to guarantee just in the minimum sealing of healing of wound, around permission moisture is transferred to it from wound.

The said porous layer that do not adhere to can be close to the said electrode of part at least.Can arrange said pick off so consequently, in use, said do not adhere to porous layer be set at the said electrode of relative substrate on the side.

The said porous layer that do not adhere to can comprise silicone, does not for example adhere to porous silicone cover layer.Said silicone cover layer can advantageously be resisted wound and adhere to.

The said porous layer that do not adhere to can comprise cellulosic material, does not adhere to the wound contact material such as the viscose glue or the acetate of (knitted) of woollen yarn knitting.

The said porous layer thickness scope that do not adhere to can be from μ m to millimeter and preferably in the scope of 50～500 μ m.

The said porous layer that do not adhere to can have the aperture of μ m to mm, and 20～500 μ m advantageously.

The said porous layer that do not adhere to can be introduced the element that can think the small size electrochemical chamber, wherein flows into Wound exudate, thereby makes itself and wound surface separate the electrical property of accurately measuring it.

Having the sterile sensor that does not adhere to porous layer can stay original position and minimize any adverse effect to wound healing simultaneously importantly in the effect duration of wound dressing.

The said porous layer that do not adhere to can comprise monolayer.Said monolayer can coated electrode.Said monolayer can coated electrode, and does not directly link to each other with electrode physics.Said monolayer can be a woven.Said monolayer can be by one or more material manufacture.

Can arrange said pick off so consequently, in use, said do not adhere to porous layer towards wound location and/or said substrate leave the wound location.

Said electrode can comprise and is used to carry out electrometric sensitive surface.Said sensitive surface can be close to the said porous layer that do not adhere to.Said at least one electrode can comprise the signal translator unit that is used for the signal of telecommunication is sent to the controller or the slave controller transmission signal of telecommunication.Said pick off can comprise at least one contact point that is used for being connected with controller.

Said electrode can comprise biocompatible material.Said electrode package argentiferous and/or argentiferous chemical compound are such as silver chloride.Said electrode can be silver/silver chloride electrode.Said electrode can comprise metal and/or metallic chemical compound such as gold, platinum and/or its chemical compound and/or carbonaceous material, such as graphite.

Said electrode part is at least formed by conductive ink.Said electrode can comprise lead.

Said electrode can prolong.Through having electrode thin, that prolong, can be minimized by electrode covered surfaces zone, thereby reduce interference wound dressing normal function and/or wound healing.

Said electrode can be connected with lead.Said connection can comprise conducting epoxy resin and/or scolder, can it is arranged in use not contact with wound.

Said pick off can further comprise electric insulation layer.Can electrode at least partly be arranged between substrate and the insulating barrier.Can the signal translator unit of part at least of said electrode be arranged between substrate and the insulating barrier.Said insulating barrier can be adhered to said substrate and/or force together with said substrate and/or integrate with said substrate around the signal translator unit of said electrode.Can arrange like this that said insulating barrier so that said sensitive surface are not covered by said insulating barrier.

Said substrate and/or insulating barrier can comprise that approval can be used for biocompatible, the flexible polymeric film of wound contact.Said substrate and/or insulating barrier can comprise polyolefin film, such as polyethylene film.Polyethylene film can be a low density polyethylene films.Said substrate and/or insulating barrier can at least partly scribble binding agent, and said binding agent can be an acryloid cement.The instance of suitable substrates and/or insulating layer material is Scapa (RTM) Bioflex (RTM) RX607P.Said substrate can comprise the two-layer polyolefin film that is bonded together.The thickness of said substrate can be 0.075mm～1mm.

Can said transducer arrangements be become with wound dressing to use and/or be the part wound dressing.Can arrange said pick off so consequently, in use, said basal surface is towards wound dressing, and the sensitive surface that does not adhere to porous layer and said electrodes exposed simultaneously faces wound.

Can said sensitive surface be arranged to wound is carried out electricity irritation.

The wound dressing of the pick off that comprises said first aspect is provided according to a second aspect of the invention.

Can said transducer arrangements be become like this so that said substrate does not adhere to porous layer and is positioned at and leaves the wound dressing place towards the wound dressing location.Can said wound dressing be arranged to so consequently, in use, the sensitive surface that does not adhere to porous layer and electrodes exposed is towards wound.

According to a third aspect of the invention we, the pick off that comprises said first aspect and the system of controller are provided.

Can said controller be arranged to be used for confirm impedance and preferably be arranged to use said pick off to carry out ac impedance spectroscopy.Said controller can comprise processor and/or memorizer.Said controller can be adapted to store look-up table, thereby according to the wound status of confirm of impedance.Can said controller be arranged to show the state of wound dressing.

Can be arranged to use the real part of one or more ac impedance measurement values and/or imaginary part to confirm wound status said controller.

Can said controller be arranged to confirm the infection that whether becomes of viscosity and/or definite wound of Wound exudate based on the ac impedance measurement value.For example, just under the situation that has the viscosity transudate aspect some of the reactive component of exsiccant wound middle impedance, can change.

Thereby can said controller be arranged to that the signal of telecommunication is put on said electrode wound is carried out electricity irritation.Can said controller be arranged to use μ A～other electric current of mA level.

Can said controller be arranged to use the voltage of 5～200mV.

Can said controller be arranged to use the frequency of 0.1～100kHz.

Typically wound pick off/dressing kept one to seven day in position.The information that depends on needs can every day, every two hours or continuously measure.

According to a forth aspect of the invention, the method for confirming wound status is provided, said method comprises the pick off that first aspect is provided and uses said pick off to confirm impedance.

Said method can comprise uses ac impedance spectroscopy to confirm impedance.Said method can comprise uses said pick off to confirm real part and/or imaginary number impedance component.Said method can comprise uses the impedance of confirming; And preferably use the real part and/or the imaginary part confirmed of at least one ac impedance measurement value; Thereby confirm wound status, such as the humidity level who occurs and/or from the infection that whether becomes of the viscosity of the transudate of wound and/or wound.

The present invention is such so that said pick off can be retained in original position between healing stage.Can follow the persistent period of wound or the healing of time correlation.For example; Because the humidity at wound interface place is important, thereby said pick off and impedance method can be used as disposable measurement use inspection moisture condition (or needing more change dressings) thereby maybe can use said system to follow the tracks of the humidity process of wound when it heals discontinuously or continuously.Therefore can carry out changing relevant concrete intervention with the humidity of humidity rate of change such as every day, it has only the pick off of not upsetting agglutination through being retained in the healing zone for a long time just maybe.Can carry out specific this type of with best practices according to wound type and intervene, ideal humidity/healing characteristic of promptly comparing venous leg ulcers with decubital ulcer can be different.

Said method can comprise with said pick off be placed on like this on the wound so that the said porous layer that do not adhere to towards wound so that the said porous layer that do not adhere to is positioned between electrode and the wound.

Can said controller be arranged in selected frequency or in frequency range, measure AC impedance.

Can said controller be arranged to measure electrical property such as AC impedance or apply the electricity irritation to wound.

According to the 5th aspect, the method for making pick off is provided, said method comprise at least one electrode and the contiguous said electrode of part at least be provided do not adhere to porous layer.What said method can comprise sensitive surface that adjacent electrode at least is provided does not adhere to porous layer.Said electrode can be the electrode of first aspect.

Can electrode be arranged in the substrate.Can with at least the part positioning of electrode between substrate and insulating barrier.

Said method can comprise insulating barrier and/or electrode and/or the substrate of part are attached to and do not adhere to porous layer at least.Not adhering to porous layer can bondedly adhere to.Can use that the armarium binding agent is bonding to adhere to the said porous layer that do not adhere to, said binding agent can comprise acrylic ester adhesive such as cyanoacrylate adhesive, for example, comprises the binding agent of cyanacrylate.The bonding of said porous layer can preferably be provided by bounding point (spot) by discontinuous adhesive phase.

Said method can be included in (patterned) China ink layer that is provided as pattern in the substrate at least partly; And be processed into the China ink (ink) of pattern thus form at least one electrode.

Said China ink (ink) can comprise at least a metallics and or slaine.Said China ink can comprise silver, gold, platinum and/or carbon, such as graphite, and/or its chemical compound.Said China ink can be silver/silver chloride China ink.

Said processing can comprise solidifies China ink.Threshold temperature is above to form at least one electrode with said China ink heating threshold time thereby said processing can be included in.Solidified additive method can be suitable for other China inks and polymer solidifies such as UV.

Can apply black pattern through silk screen printing.Can apply black pattern through intaglio printing, counter-rotating (reverse) intaglio printing, doctor (doctor blade), inkjet printing and/or flexographic plate (flexographic) printing.

Said method can comprise electrode and/or the substrate that insulating barrier is applied at least part.Said method can comprise that the electrode that makes part is not insulated layer and covers.Unlapped electrode part can comprise sensitive surface.Can use said insulating barrier through bonding.Can use acryloid cement to use said insulating barrier.

Said method can comprise removes unnecessary substrate and/or insulating barrier.With this, pick off can provide that minimal surface is long-pending to hinder wound fluid such as exudate and/or blood to minimize from the barrier that wound flows to wound dressing or outer surface to cause the minimize interference of wound healing process and to make.

The accompanying drawing summary

To only different aspect of the present invention be described according to accompanying drawing now through by way of example, wherein:

Fig. 1 is the sketch map of wound pick off;

Fig. 2 is the exploded view of the pick off of Fig. 1;

Fig. 3 is as the part of the method for the pick off of preparation Fig. 1, uses the sketch map that insulation covers;

Fig. 4 is the sketch map of arrangement of electrodes of the pick off of Fig. 1;

Fig. 5 is the sketch map of pick off of Fig. 1 of the part assembling behind the excess stock of pruning away;

Fig. 6 is a sketch map, and it shows not adhering to adhering to of porous layer as the part of the manufacturing of the pick off of Fig. 1;

Fig. 7 shows the pick off of the Fig. 1 that is attached to controller, and

Fig. 8 is presented at deposited wound with wound dressing of the present invention of two healing stages.

Detailed description of the drawings

Fig. 1 shows pick off 15, and pick off 15 comprises two

electrode

10a, 10b in the substrate of being processed by electrically insulating material 15, and

electrode

10a, 10b do not adhere to porous material 25 by monolayer and

cover.Electrode

10a, 10b are the silver/silver chloride electrodes of silk screen printing, and it has natural antibacterial functions and can stop albumen to adhere to and growth of microorganism.

Fig. 2 to 5

shows electrode

10a, 10b in greater detail.Each has

sensitive surface

30a, 30b,

contact point

40a, 40b that signal

translator unit

35a, 35b and being arranged to is connected with controller.

Sensitive surface

30a, 30b are arranged to be used to obtain electrical measurement, and synchronous

signal translator unit

35a, 35b are arranged between

sensitive surface

30a, 30b and

contact point

40a, 40b, transmit signal.

Use other binding agent of medical grade that insulating barrier 20 is fixed to substrate 15.The signal translator unit 35a of

electrode

10a, 10b, 35b are clipped between insulating barrier 20 and the substrate 15.Insulating barrier 20 is attached to substrate 15 on every side at signal translator unit 35a, the 35b of electrode 10a, 10b.The size of insulating barrier 20 is such so that it covers

signal translator unit

35a, 35b basically, but

sensitive surface

30a, 30b and

contact point

40a, 40b are exposed.With this, have only paired, local sensitive surface zone 30a, the 30b of said electrode to be exposed to wound.This allows to carry out partial, control and reproducible measurement.

The surface area of

electrode

10a, 10b is minimized and the form of the arrangement of electrodes of said electrodes use elongation.Substrate 15 is pruned with

near electrode

10a, 10b with insulating barrier 20, and is as shown in fig. 5, so that pick off 5 is long and thin.With this, the obstruction from the liquid stream of wound is minimized.In one embodiment,

electrode

10a, 10b adopt the form of microelectrode.Yet, to use for other, the size of the pick off 5 of 0.1mm～10cm is enough.

Do not adhere to porous layer 25 and cover on the arrangement of electrodes, and especially cover

sensitive surface

30a, 30b is last.This layer 25 can be made such as being surrounded by the cellulose that does not adhere to silicone by any suitable material.Use point-like (spotted) adhesive attachment will not adhere to porous layer 25 and be attached to insulating barrier 20 through other cyanacrylate binding agent of medical grade.Through covering

sensitive surface

30a, 30b with layer 25, this is avoided contact with the wound direct physical, and meanwhile allows wound fluid or dressing liquid as its

arrival contact

30a, 30b from the wound inflow or the porous layer 25 that bleeds the time.

Through having porous layer 25, partial, fixed volume environment is provided near induction region near contact 30a, 30b.This helps to guarantee in wet, moistening or dried wound, to have constant thickness with the sensitive surface 30a of

electrode

10a, 10b, the wound liquid layer that 30b contacts.This has improved the electrometric concordance of wound fluid, thereby the while still allows the exchange of wound fluid that the reliable readings of wound status is provided.

Porous layer 25 allows the diffusion of ions and metabolite, thereby even in the situation of different dressing types the gradually changing of wound fluid composition, or fading away of wound can provide consistent result with drying.In fact, porous layer 25 is for measuring the volume borders that provides consistent.Because exist under the situation of liquid preferred current path always to pass through limited volume,, improving the measurement concordance thus so said sensitive surface is included in the measuring chamber that is limited porous layer effectively.The measurement of this constant volume arranges that it is favourable characterizing for the wound that carries out through electrical impedance research, the sign of especially carrying out through AC impedance.

In use, pick off 5 be placed on the wound porous layer 25 wherein towards wound and substrate 15 towards leaving wound.Controller 45 links to each other with contact point 40a, the 40b of

electrode

10a, 10b, as shown in Fig. 7.Controller 45 is arranged to use the electrode 10a of pick off 5,10b to carry out ac impedance measurement.Controller 45 further is adapted to calculate like the electrode 10a that uses pick off 5, the real part and the imaginary part of 10b measured impedance.Controller 45 is configured to have processor and memorizer (not shown).Said memorizer is arranged to store look-up table.Said look-up table writes down real number and the imaginary value like the impedance of the corresponding wound status of passing through controller 45 measurements via pick off 5.

Thereby controller 45 is arranged to that the signal of telecommunication is applied to said electrode carries out electricity irritation to wound.Controller 45 can be arranged to use μ A～other electric current of mA level.Said controller can be arranged to use the voltage of 5～200mV and the frequency of 0.1～100kHz scope.Typically said wound pick off/dressing kept one to seven day in position.The information that depends on needs can every day, per two hours or measure continuously.

When bone dry, the coefficient that trends towards quiescent value and AC impedance like measured impedance between

electrode

10a, 10b enough shows this usually.When wet fully, the short circuit between controller 45 measurement electrode 10a, the 10b.The resistance value that changes between short circuit and the open circuit is illustrated in the intensity of variation of the humidity in the electric pathway between two electrode 10a, the 10b.Through with the function measurement of AC impedance, can obtain the measure of time of wound dressing aquation subsequently as the time.This provides the indication of wound healing process again.

The real part that the processor of controller 45 is arranged to confirm the measured value resistance value is with imaginary part and with them and the value comparison that is stored in the look-up table.Can operate the said processor retrieval wound status relevant and wound status is offered display 50, thereby allow the operator to confirm the state of wound apace with measured impedance.Some wound status and associated impedances thereof are specified in the table 1.

Wound status	Impedance
		Do	Trend towards open circuit
Doing of some moisture arranged	Limited but high
		Moistening	Measurable
What trend towards wetting is moistening	Low
		Wet	Trend towards short circuit

Table 1

Said impedance can be used for confirming the character of transudate, for example, and the viscosity of transudate.This can be used for confirming the healing state of wound again, for example, and from normally healing into the variation of infection.

Thereby can follow the tracks of said impedance in time is provided between healing stage from the water reduction rate of wound or concrete humidity level's characteristic in time; And it is compared with the anticipatory data of concrete wound type, thereby allow to carry out new clinical intervention based on measuring such as the humidity rate of change and/or the target humidity of specifying day etc.

Through having the protectiveness porous layer 25 that keeps wound fluid, pick off 5 of the present invention even in the environment of pressurization, for example can be effective under tight Wound bandage or in compression bandage.This is because when pick off 5 is pressed into wound tissue, obtaining the reading of autobiography sensor 5 can be not easy to change, because wound fluid in the induction path and moisture more possibly and can not be extruded or reduce by porous layer 25 reservations.In addition, pick off 5 of the present invention can be advantageously used in negative pressure therapy, has relative repellence because it changes the fraudulence of moisture loss and relevant reading.

Can use any suitable technique to make up pick off 5.For example, can use the medical rank that on a surface, scribbles acryloid cement such as Bioflex (RTM) RX607P that makes by Scapa, do not adhere to, two 16cm of low density polyethylene films take advantage of the 25cm sheet to make said pick off.Thereby the adhesive surface that use is faced is bonded together said two films and forms substrate, notes getting rid of the bubble between the sheet.As an example, the thickness of substrate 15 can be about 0.15mm.

Then said substrate is placed in the screen printing frame.Thereby the silk screen that makes screen printing frame forms pattern and produces

electrode

10a, 10b, comprises

sensitive surface

30a, 30b, the shape of

signal translator unit

35a, 35b and contact point 40a, 40b.Then silver/silver chloride China ink is screen-printed in the electrode pattern in the substrate 15.Thereby the substrate 15 that will be printed on the silver/silver chloride China ink pattern of the shape with

electrode

10a, 10b was then solidified said China ink in 30 minutes and is formed

electrode

10a, 10b 80 ℃ of heating.

Use a lip-deep medical rank acryloid cement being coated in the medical rank low density polyethylene films of other one deck said polyethylene film to be adhered on peripheral part of

signal translator unit

35a, 35b and substrate 15 of

electrode

10a, 10b then, thereby form insulating barrier 20.As an example, the thickness of insulating barrier 20 approximately is 0.076mm.

As shown in Fig. 3, insulating barrier 20 extends to the sensitive surface 30a of

electrode

10a, 10b, the edge of 30b, exposes to cause

sensitive surface

30a, 30b, and electrode 10a, the signal translator unit 35a of 10b, 35b are sealed between substrate 15 and the insulating barrier 20 simultaneously.Use cutting knife to remove unnecessary substrate 15 and minimize with insulating barrier 20 so that surface area, as shown in fig. 5.The insulated copper wire that uses conducting epoxy resin will be used for being connected with controller 45 is attached to contact point 45a, the 45b of

electrode

10a, 10b.

As shown in figure 6, make then the rolling viscose porous layer 25 that scribbles silicone with towards and electrode 10a, the sensitive surface 30a of 10b, the 30b of contiguous porous layer 25 adhere to.For doing like this, 15 of the outer surface of being coated with for porous layer 25 to give insulating barrier 20 with priming paint (primer) and/or the substrates of exposure are with medical rank cyanacrylate binding agent.Thereby then porous layer 25 is attached to the surface that binding agent is a little arranged and forms pick off 5.After adhering to porous layer 25, can use oxirane to give pick off 5 sterilizations.

Equipment of the present invention allows best wound healing and monitoring.Fig. 8 shows the use effect that does not adhere to pick off as described herein when being applied to the patient with leg ulcer wound.It is wet to moistening (3.142k Ω) that the 3rd all wounds of healing remain.The 4th all ulcer heals and wound is (the 305k Ω) that does.Because the said porous layer that do not adhere to, said sensor device do not adhere to skin and ulcer well healing.

The variation that the technical staff will understand disclosed layout is possible and do not deviate from scope of the present invention.For example, although above working of an invention scheme has been described to pass through to use suitable China ink silk screen printing forms in substrate 15

electrode

10a, 10b, in the practice, also can use other arrangement of electrodes.For example,

electrode

10a, 10b can be formed by lead.Although

electrode

10a, 10b are described to advantageously form from silver/silver chloride, can use other electrod compositions, such as electrode based on copper, gold, platinum or carbon.

In addition, although porous layer 25 is described to comprise the rolling fiber film that scribbles silicone, can use other not adhere to porous material.In addition, although in above embodiment, substrate 15 makes up from low density polyethylene (LDPE) band (tape) with insulating barrier 20, can use other not adhere to biocompatible material.Although the sensor 5 is advantageously used in the monitoring AC impedance, can said pick off be used for a series of measurement and/or methods based on electricity extraly or alternatively, measure conductance measurement and/or electricity irritation wound such as pH.Likewise, can pick off 5 be arranged to be independent or integrate or be attached to wound dressing with wound dressing.Therefore above description to specific embodiments only is exemplary, and unconfined intention.To the technical staff clearly will be can carry out little change and the operation significant change that do not make description.

Claims

1. wound pick off, it comprises at least one electrode and does not adhere to porous layer near the said electrode of part at least.

2. according to the wound pick off of claim 1, the wherein said porous layer that do not adhere to is medical surface, material or cover layer.

3. according to the wound pick off of claim 2, wherein said medical surface, material or cover layer are biocompatible and/or nonirritating surface, material or cover layer.

4. according to each wound pick off in the aforementioned claim, wherein said pick off comprises two or more electrodes.

5. according to each wound pick off in the aforementioned claim, wherein said at least one electrode is disposed in the substrate.

6. according to the wound pick off of claim 5, wherein said substrate is not adhere to substrate and/or electrical insulating substrate.

7. according to each wound pick off in the aforementioned claim, wherein said at least one electrode prints.

8. according to each wound pick off in the aforementioned claim, the wherein said porous layer that do not adhere to separates with said at least one electrode.

9. according to each wound pick off in the aforementioned claim, the wherein said porous layer that do not adhere to covers said at least one electrode fully.

10. according to each wound pick off in the aforementioned claim, the wherein said porous layer that do not adhere to is nonconducting.

11. according to each wound pick off in the aforementioned claim, the wherein said contiguous said electrode of part at least of porous layer that do not adhere to.

12. according to each wound pick off in the claim 5 to 11, wherein arrange so said pick off so that said do not adhere to porous layer be set at the said electrode of said relatively substrate on the side.

13. according to each wound pick off in the aforementioned claim, the wherein said porous layer that do not adhere to comprises silicone, preferred silicone cover layer.

14. according to each wound pick off in the aforementioned claim, the wherein said porous layer that do not adhere to comprises cellulosic material.

15. according to each wound pick off in the aforementioned claim, the wherein said porous layer thickness that do not adhere to is 50～500 μ m and/or the aperture with 20～500 mu m ranges.

16. according to each wound pick off in the claim 5 to 15, wherein, in use, said do not adhere to porous layer towards the wound location and/or said substrate leave the wound location.

17. according to each wound pick off in the aforementioned claim, wherein at least one electrode comprises and is used to carry out electrometric sensitive surface.

18. according to the wound pick off of claim 17, the contiguous said porous layer that do not adhere to of wherein said sensitive surface.

19. according to each wound pick off in the aforementioned claim, wherein said electrode comprises biocompatible material.

20. according to each wound pick off in the aforementioned claim, wherein said electrode package argentiferous and/or silver compound are such as silver chloride.

21. according to each wound pick off in the aforementioned claim, wherein said electrode part is at least formed by conductive ink.

22. according to each wound pick off in the aforementioned claim, wherein said electrode extends.

23. according to each wound pick off in the aforementioned claim, wherein said pick off comprises electric insulation layer.

24. according to the wound pick off of claim 23, wherein the said electrode of part is set between said substrate and the said insulating barrier at least.

25. according to the wound pick off of claim 24, the signal translator unit of part at least of wherein said electrode is set between said substrate and the said insulating barrier and said sensitive surface can't help said insulating barrier and covered.

26. according to each wound pick off in the claim 23 to 25, wherein said insulating barrier is adhered to said substrate and/or forces together with said substrate and/or integrate with said substrate around the signal translator unit of said electrode.

27. according to each wound pick off in the claim 23 to 26, wherein said substrate and/or insulating barrier comprise biocompatible, flexible polymeric film.

28. according to each wound pick off in the claim 5 to 27, wherein said substrate and/or insulating barrier comprise polyolefin film, said polyolefin film randomly is a polyethylene film.

29. according to the wound pick off of claim 28, wherein said substrate and/or insulating barrier part at least scribble binding agent, said binding agent randomly is an acryloid cement.

30. according to each wound pick off in the claim 5 to 29, the thickness of wherein said substrate is 0.075mm～1mm.

31. according to each wound pick off in the aforementioned claim, wherein said pick off is arranged to use and/or be with wound dressing the wound dressing of part.

32. according to the wound pick off of claim 31, wherein arrange said pick off like this, so that in use, said basal surface is towards said wound dressing, the said sensitive surface that does not adhere to porous layer and said electrodes exposed faces wound simultaneously.

33. according to each wound pick off in the aforementioned claim, wherein said sensitive surface is arranged to carry out the electricity irritation to wound.

34., wherein be provided as counter electrode and be used to measure the wound aquation according to each wound pick off in the aforementioned claim.

35. each wound pick off in the aforementioned claim, wherein said at least one electrode comprises the signal measurement part, and said signal measurement part is connected with being used to allow to pass on the signal translator unit from the measured value of said measure portion.

36. the wound pick off of claim 35, the signal translator unit of wherein said electrode and wound environment are basic electric insulations.

37. the wound pick off of claim 35 or claim 36, wherein said signal translator unit is covered by electric insulation layer.

38. a wound dressing, it comprises according to each pick off in the claim 1 to 37.

39. a system, it comprises according to each pick off and controller in the claim 1 to 37.

40. according to the system of claim 39, wherein said controller is arranged to use said pick off to confirm impedance and preferably is arranged to use said pick off to carry out ac impedance spectroscopy.

41. according to the system of claim 39 or claim 40, wherein said controller comprises processor and memorizer, said memory storage is used for the look-up table of confirming wound status based on impedance.

42. according to each system in the claim 39 to 41, wherein said controller is arranged to use the real part of one or more ac impedance measurement values and/or imaginary part to confirm wound status.

43. according to each system in the claim 39 to 42, wherein said controller is arranged to confirm based on the ac impedance measurement value whether the viscosity of Wound exudate and/or definite wound infect.

44. confirm the method for wound character, it comprise provide according in the claim 1 to 38 each pick off or according in the claim 39 to 43 each system and use said pick off to confirm impedance.

45. according to the method for claim 44, it comprises and uses ac impedance spectroscopy to confirm impedance.

46. according to claim 45 method, it comprises that impedance of use confirming confirms wound status such as the humidity level who occurs and/or whether infect from the viscosity and/or the wound of the transudate of wound.

47. according to each method in the claim 44 to 46, it is included in said pick off of healing stage chien shih and wound communication.

48. according to each method in the claim 44 to 47, it comprises the persistent period of confirming wound or the healing of time correlation.

49. according to the method for claim 48, it comprises confirms that humidity changes.

50. according to each method in the claim 44 to 49, it comprises and is placed on the wound said pick off so that the said porous layer that do not adhere to faces wound, so that the said porous layer that do not adhere to is positioned between said electrode and the said wound.

51. make the method for pick off, it comprise at least one electrode and the contiguous said electrode of part at least be provided do not adhere to porous layer.

52. according to the method for claim 51, what it comprised sensitive surface that at least contiguous said electrode is provided does not adhere to porous layer.

53. according to the method for claim 51 or claim 52, wherein said pick off is according to each pick off in the claim 1 to 38.

54. according to each method in the claim 51 to 53, wherein said electrode be set in the substrate and/or at least the said positioning of electrode of part between substrate and insulating barrier.

55. according to each method in the claim 51 to 54, it comprises said insulating barrier and/or the said electrode and/or the said substrate of part are attached to the said porous layer that do not adhere at least.

56. method according to claim 55; It comprises the bonding said porous layer that do not adhere to that adheres to; Preferred use that the armarium binding agent is bonding to adhere to the said porous layer that do not adhere to, said armarium binding agent randomly is that acrylic ester adhesive is such as cyanoacrylate adhesive.

57. according to the method for claim 56, wherein said do not adhere to porous layer bonding by discontinuous adhesive phase, preferably provide by adhesive spots.

58. according to each method in the claim 51 to 57, thereby it is included in the China ink that is provided as the China ink layer of pattern in the said substrate of part at least and handles said one-tenth pattern and forms at least one electrode.

59. according to the method for claim 58, wherein said China ink comprise at least a metallics with or slaine, said metallics or slaine preferably include silver, gold, platinum and/or carbon, such as graphite, and/or its chemical compound.

60. according to the method for claim 59, wherein said China ink comprises silver and/or silver salt such as silver chloride.

61., wherein apply said black pattern through silk screen printing according to each method in the claim 58 to 60.

62. according to each method in the claim 51 to 61, it comprises insulating barrier is applied to said electrode and/or the substrate of part at least and the said electrode of part is not covered by said insulating barrier.

63. according to each method in the claim 61 to 62, it comprises removes unnecessary substrate and/or insulating barrier.